The H. pylori Antigen Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of Helicobacter pylori antigens in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of H. pylori infection.

Helicobacter pylori (also known as Campylobacter pylori) is a spiral-shaped with a typical flagellum, Gram negative bacteria, infecting gastric mucosa. It causes several gastro-enteric diseases such as non-ulcerous dyspepsia, gastric and duodenal ulcer, active gastritis and can even increase the risk of stomach adenocarcinoma, so as to be classified as carcinogen agent type I.

Store at 4 ~ 30 º C in the sealed pouch for 24 months.

Keep away from direct sunlight, moisture, and heat.

Do not freeze.

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1) Best results will be obtained if the assay is performed within 6 hours after collection.
2) Unscrew and remove the dilution tube applicator stick. Be careful not to spill or spattersolution from the tube. Collect specimens by inserting the applicator stick intoat least 4different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of apea).
3) Place the applicator stick back into the tube and screw the cap tightly. Be careful not tobreakthe tip of the dilution tube. 4) Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.
2. Testing
1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label thetestwith patient or control identification. To obtain a best result, the assay should be performedwithin one hour.
2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube verticallyanddispense 2 drops of solution into the specimen well (S) of the test device.
Avoid trapping air bubbles in the specimen well (S), and do not drop any solutioninobservation window.
As the test begins to work, you will see color move across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes.Do not read after 20 minutes.
4. Results reading:
1) POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
2) NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
3) INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. 

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